Helping innovators navigate the world of medical device regulation
Bringing new innovations into the healthcare sector is associated with many challenges. One of them is to have the innovation properly tested and documented, taking all legal aspects into account from the start.
Different regulations come into play depending on the type of innovation and whether it is software based, embedded or not, invasive or non-invasive.
The Legal Value Chains project aims to map and analyze relevant regulations and apply them to real-life cases in order to generate knowledge to be shared with innovators in academia, healthcare and industry.
Examples of relevant regulations relate to patient data, data privacy and the new European medical device regulation coming into force in May 2021.
The project is part of the MedTech4Health National Development Program for implementation and financed by Sweden’s Innovation Agency and Region Västra Götaland Development Fund.
Sahlgrenska Science Park – project lead
GU Law – overall analysis legal framework and regulations
MedTech West – research input